Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System
FDA 510(k) K001219 · Biomedical Ent., Inc.
510(k) numberK001219
Submission
- Device name
- Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System
- Applicant
- Biomedical Ent., Inc.
San Antonio, TX, US - Received
- April 17, 2000
- Decision date
- June 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System cleared by the FDA?
Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System (K001219) received a 510(k) decision of Substantially Equivalent on June 21, 2000, 65 days after the submission was received.
What is the product code of K001219?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.